Section G: Internal Quality Control - Hologic Genius Operator's Manual

1
I
NTRODUCTION
Table 3. Guidance and manufacturer's declaration—electromagnetic immunity
Guidance and manufacturer's declaration—electromagnetic immunity
The Digital Imager is intended for use in the electromagnetic environment specified below. The customer or the user of
the Digital Imager should assure that it is used in such an environment.
Immunity test IEC 60601-1-2 test level
Conducted RF 3 Vrms, 0.15 MHz–80 MHz,
80 % AM at 1 kHz
IEC 61000-4-6
6 Vrms, in ISM band between
0.15 MHz and 80 MHz,
80 % AM at 1 kHz
Radiated RF 3 V/m, 80 MHz–2.7 GHz,
80 % AM at 1 kHz
IEC 61000-4-3
Radiated electric Test levels as defined in
immunity to Table 9 of IEC 60601-1-2
proximity fields from
RF wireless
communications
equipment
IEC 60601-1-2
SECTION
G
INTERNAL QUALITY CONTROL
Power On Self Test (POST)
At the time the Digital Imager is powered on (refer to "Applying Power to the Equipment" on
page 4.3), the system goes through a self-diagnostic test. All the electrical, mechanical and software/
communication systems are tested to confirm each performs properly. The operator is alerted to any
malfunction via a message on the user interface. If the system does not function or there are
persistent errors, contact Hologic Technical Support. Refer to Chapter 8, Service Information.
1.24 Genius™ Digital Imager Operator's Manual
Compliance level
3 Vrms, 6 Vrms
3 V/m
up to 28 V/m
Electromagnetic
environment—guidance
Conducted electrical
fields should be that of a
typical commercial or
hospital environment.
Radiated electrical fields
should be that of a typical
commercial or hospital
environment
Immunity to proximity
fields from RF wireless
communications
equipment